Temporal Changes of Lactate in CLASSIC Patients

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Drug: Resuscitation fluid

• Registration Number: NCT05629780
• Lead Sponsor: Karolinska University Hospital

Brief Summary

This study aim to examine if randomization to different treatment strategies had any effect on the time to normalization of lactate in intensive care patients treated for septic shock.

Detailed Description

This is a retrospective analysis of a subset of patients included in the Conservative versus Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial.

In the CLASSIC trial patients with septic shock were randomized to either traditional (liberal) strategy for fluid treatment or a more conservative regimen. The study was an international multicenter clinical trial (clinicaltrials.gov NCT03668236), and results were published in New England Journal of Medicine in June 2022 (DOI: 10.1056/NEJMoa2202707).

In this substudy the investigator extract all lactate values for the study period from all patients included from Karolinska University Hospital, Sundsvall and Södersjukhuset (Sweden), participating centers on Zealand (Denmark), and Plzen University Hospital (Czech Republic). Baseline data, treatment allocation and amount of fluids administered are collected as well as outcome from CLASSIC study.

Primary outcome is time to lactate normalization (\< 2mmol/L). Secondary outcome is lactate concentration over the first 72 hours (as peak lactate for the time intervals 0-3, 3-6, 6-12, 12-24 and then each 12h-period between 24 and 72 hours).

The subgroup with blood lactate \> 4mmol/L will be analyzed separately for the same end points.

Time to resolution of hyperlactatemia will be modelled with a competing risks regression. Death and discharge will be competing outcomes, and administrative censoring imposed 72 hours after randomisation.

Factors associated with time to lactate normalization will be examined through regression analysis. Factors that show a relationship on univariate analysis will be included in a multivariate analysis.

Study Timeline

• Study Start: 2022-09-29
• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-11-29
• Primary Completion: 2022-12-28
• Study Completion: 2023-06-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 777

Inclusion Criteria

• Participation in CLASSIC trial in any of the participating centres

Exclusion Criteria

• Lack of sufficient data for analysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative	Resuscitation fluid	Resuscitation fluids were only given under certain pre-defined criteria

Primary Outcome Measures

Name	Time	Method
Time to resolution of hyperlactemia	72 hours	Blood lactate \< 2.0 mmol/L

Secondary Outcome Measures

Name	Time	Method
Temporal changes in lactate concentrations over time	72 hours	Difference in blood lactate at during the first 72h from enrollment

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden